Identity
- Trade Name
- HSEU FDA UDI
- Generic Name
- Gingival retraction solution FDA UDI
- Device Name
- Intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative andoperative dentistry used with gingival retraction cord. It is also intended to facilitate the insertion of the cord into the sulcus. FDA UDI
- Model / Reference
- 5702540 FDA UDI
- Description
- Intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative andoperative dentistry used with gingival retraction cord. It is also intended to facilitate the insertion of the cord into the sulcus. FDA UDI
Identifiers
- Catalog Number
- 5702540 FDA UDI
- Primary DI / UDI-DI
- 10304040151447 FDA UDI
- FDA Product Code
- MVL FDA UDI
- GMDN Term
- Gingival retraction solution FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Gingival retraction solution
Hseu by Henry Schein, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Henry Schein, Inc.
Sources (1)
- FDA UDI d428b3fe-6d36-48ed-a6c2-158d9ff7c064 35 fields · synced May 30, 2026